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Measurements From Stool to Support Dietary Change

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04037306
Recruitment Status : Terminated (Weight loss center programming suspended due to COVID-19 pandemic)
First Posted : July 30, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of the study is to evaluate if daily feedback on food-derived metabolites in stool enhances an individual's ability to make and/or sustain a dietary change.

Condition or disease Intervention/treatment Phase
Diet Habit Feeding Behavior Behavior, Health Behavioral: Butyrate Feedback Behavioral: Fiber Feedback Not Applicable

Detailed Description:

This is a research study to find out how people respond to information about food-derived compounds measured in their stool.

This study will take place over a three-week period. For these three weeks, participants in a medical weight loss program will be asked to collect samples of their stool daily from Monday to Friday, with optional sampling on weekends. We will measure the amount of butyrate, a breakdown product of fiber, in each sample provided and return this measurement by text message. Participants will be randomized into two groups: one group will have new measurements returned the day after providing each stool sample, and another will have their measurements returned all at once, at the end of the study. Both groups will also receive a daily text message report of their fiber intake, based on the foods they ordered at the weight loss facility cafeteria.

The greatest risks of the study include the possibility of infection while sampling stool, possible gastrointestinal discomfort from changes to the diet, and potential loss of confidentiality.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Measurements From Stool to Support Dietary Change
Actual Study Start Date : July 30, 2019
Actual Primary Completion Date : March 10, 2020
Actual Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Rapid Feedback
Participants received daily feedback on both fiber intake and stool butyrate measurements.
Behavioral: Butyrate Feedback
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.

Behavioral: Fiber Feedback
Estimated fiber consumption from menu records of weight loss facility.

Active Comparator: Delayed Feedback
Participants received daily feedback on fiber intake and one-time feedback on stool butyrate measurements at the end of the study period.
Behavioral: Butyrate Feedback
Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.

Behavioral: Fiber Feedback
Estimated fiber consumption from menu records of weight loss facility.




Primary Outcome Measures :
  1. Change in nutrient intake, as estimated from menu selections [ Time Frame: Baseline, Week 2, and Week 3 ]
    Nutrient intake estimated in grams per day, summed over total menu selections.


Secondary Outcome Measures :
  1. Change in butyrate concentration [ Time Frame: Baseline, Week 2, and Week 3 ]
    Butyrate measurements by gas chromatography, reported in mM (millimolar).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the ages of 18 and 80
  • must be a client of the DFC (Duke Diet and Fitness Center) weight loss program for at least four continuous weeks.
  • must have a smartphone

Exclusion Criteria:

  • have diagnosis of Crohn's disease
  • have known stricture (narrowing) of the intestine
  • have any past history of intestinal obstruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037306


Locations
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United States, North Carolina
Duke University Diet and Fitness Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04037306    
Other Study ID Numbers: Pro00094657
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Fiber